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FDA 510(k)

Pivot Insulin Delivery System

K-Number: K253534 · 2026-04-08

ApplicantModular Medical
Decision Date2026-04-08
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Pivot Insulin Delivery System is a medical device manufactured by Modular Medical. It received FDA 510(k) clearance on 2026-04-08 under approval number K253534. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pivot Insulin Delivery System?

Pivot Insulin Delivery System is a medical device that received FDA 510(k) clearance on 2026-04-08. It is manufactured by Modular Medical. The 510(k) number is K253534.

When was Pivot Insulin Delivery System approved by the FDA?

Pivot Insulin Delivery System received FDA 510(k) clearance on 2026-04-08, under approval number K253534.

What company makes Pivot Insulin Delivery System?

Pivot Insulin Delivery System is manufactured by Modular Medical.

What is the FDA product code for Pivot Insulin Delivery System?

The FDA product code for Pivot Insulin Delivery System is LZG.

Related Clinical Trials

NCT07039942 French Prospective Multicentric Study in Real World RECRUITING NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT06728059 Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm COMPLETED NCT07458243 A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population NOT_YET_RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 40965839 A multi-stakeholder perspective on medical devices for children and adolescents with type 1 diabetes: huge unmet needs for the smallest. Journal of pediatric endocrinology & metabolism : JPEM (2025)

Related Devices (Code: LZG)

K162080t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc. K160056t:slim Insulin Delivery SystemTandem Diabetes Care, Inc. K160482t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc. K160252OmniPod Insulin Management SystemInsulet Corporation K162296OmniPod Insulin Management SystemInsulet Corporation K180045Omnipod DASH Insulin Management SystemInsulet Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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